The Presentation will take the reader through various ethical issues in biomedical research. It covers topics like The Nuremberg Code, Declaration of Helsinki, Declaration of Geneva, selected code and regulations that guide research with human subjects, etc.
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
The Presentation will take the reader through various ethical issues in biomedical research. It covers topics like The Nuremberg Code, Declaration of Helsinki, Declaration of Geneva, selected code and regulations that guide research with human subjects, etc.
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
Principles of essentiality
Principles of voluntariness, informed consent and community agreement
Principles of non-exploitation
Principles of privacy and confidentiality
Principles of precaution and risk minimisation
Principles of professional competence
Principles of accountability and transparency
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
Ethics in Clinical Research: Challenges and SolutionsClinosolIndia
Ethics in clinical research is of paramount importance to protect the rights, safety, and well-being of human participants involved in studies. However, there are several challenges that researchers and regulatory bodies face in ensuring ethical practices. Let's discuss some of these challenges and potential solutions
Principles of essentiality
Principles of voluntariness, informed consent and community agreement
Principles of non-exploitation
Principles of privacy and confidentiality
Principles of precaution and risk minimisation
Principles of professional competence
Principles of accountability and transparency
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
Ethics in Clinical Research: Challenges and SolutionsClinosolIndia
Ethics in clinical research is of paramount importance to protect the rights, safety, and well-being of human participants involved in studies. However, there are several challenges that researchers and regulatory bodies face in ensuring ethical practices. Let's discuss some of these challenges and potential solutions
Human subject research is systematic, a scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. https://en.wikipedia.org/wiki/Human_subject_research
Unit 8. Ethical Considerations in Reseaerch.pptxshakirRahman10
Ethical Consideration in Research:
Objectives:
1. Define the terms related to ethics in research
2. Discuss historical events of ethical mischiefs and evolution of ethics as protecting human rights
3. Discuss the ethical principles, declaration of Helsinki and research code of ethics
4. Describe different types of informed consent, i.e. verbal, written, individual and institutional consent.
5. Produce a meaningful informed consent form.
6. Identify role and importance of ethical considerations in research.
Ethical Considerations in Research:
Ethical considerations in research are a set of principles that guide the research designs and practices.
Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.
The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways.
What you decide to research and how you conduct that research involve key ethical considerations.
Ethical considerations work to:
Protect the rights of research participants
Enhance research validity
Maintain scientific or academic integrity.
History of Research Ethics:
Nuremberg Code
Dec. 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity.
Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently crippled as a result.
As a direct result of the trial, the Nuremberg Code was established in 1948, stating that “The voluntary consent of the human subject is absolutely essential,” making it clear that subjects should give consent and that the benefits of research must outweigh the risks.
Although it did not carry the force of law, the Nuremberg Code was the first international document which advocated voluntary participation and informed consent.
Thalidomide
In the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA.
The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus.
Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide.
U.S. Senate hearings followed and in 1962 the so-called “Kefauver Amendments” to the Food, Drug, and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety.
For the first time, drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them.
The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles, or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context, “research” includes both medical and behavioral studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health.
Factors Associated with Anemia among Pregnant Women of Underprivileged Ethnic...Prabesh Ghimire
Abstract
Background. This study aims at determining the factors associated with anemia among pregnant women of underprivileged ethnic groups attending antenatal care at the provincial level hospital of Province 2. Methods. A hospital-based cross-sectional study was carried out in Janakpur Provincial Hospital of Province 2, Southern Nepal. 287 pregnant women from underprivileged ethnic groups attending antenatal care were selected and interviewed. Face-to-face interviews using a structured questionnaire were undertaken. Anemia status was assessed based on hemoglobin levels determined at the hospital’s laboratory. Bivariate and multiple logistic regression analyses were used to identify the factors associated with anemia. Analyses were performed using IBM SPSS version 23 software. Results. The overall anemia prevalence in the study population was 66.9% (95% CI, 61.1–72.3). The women from most underprivileged ethnic groups (Terai Dalit, Terai Janajati, and Muslims) were twice more likely to be anemic than Madhesi women. Similarly, women having education lower than secondary level were about 3 times more likely to be anemic compared to those with secondary level or higher education. Women who had not completed four antenatal visits were twice more likely to be anemic than those completing all four visits. The odds of anemia were three times higher among pregnant women who had not taken deworming medication compared to their counterparts. Furthermore, women with inadequate dietary diversity were four times more likely to be anemic compared to women having adequate dietary diversity. Conclusions. The prevalence of anemia is a severe public health problem among pregnant women of underprivileged ethnic groups in Province 2. Being Dalit, Janajati, and Muslim, having lower education, less frequent antenatal visits, not receiving deworming medication, and having inadequate dietary diversity are found to be the significant factors. The present study highlights the need of improving the frequency of antenatal visits and coverage of deworming program in ethnic populations. Furthermore, promoting a dietary diversity at the household level would help lower the prevalence of anemia. The study findings also imply that the nutrition interventions to control anemia must target and reach pregnant women from the most-marginalized ethnic groups and those with lower education
Factors Associated with Enrolment of Households in Nepal’s National Health In...Prabesh Ghimire
Abstract
Background: Nepal has made remarkable efforts towards social health protection over the past several years. In 2016, the Government of Nepal introduced a National Health Insurance Program (NHIP) with an aim to ensure equitable and universal access to healthcare by all Nepalese citizens. Following the first year of operation, the scheme has covered 5 percent of its target population. There are wider concerns regarding the capacity of NHIP to achieve adequate population coverage and remain viable. In this context, this study aimed to identify the factors associated with enrolment of households in the NHIP.
Methods: A cross-sectional household survey using face to face interview was carried out in 2 Palikas (municipalities) of Ilam district. 570 households were studied by recruiting equal number of NHIP enrolled and non-enrolled households. We used Pearson’s chi-square test and binary logistic regression to identify the factors associated with household’s enrolment in NHIP. All statistical analyses were performed using IBM SPSS version 23 software.
Results: Enrolment of households in NHIP was found to be associated with ethnicity, socio-economic status, past experience of acute illness in family and presence of chronic illness. The households that belonged to higher socio-economic status were about 4 times more likely to enrol in the scheme. It was also observed that households from privileged ethnic groups such as Brahmin, Chhetri, Gurung, and Newar were 1.7 times more likely to enrol in NHIP compared to those from underprivileged ethnic groups such as janajatis (indigenous people) and dalits (the oppressed). The households with illness experience in 3 months preceding the survey were about 1.5 times more likely to enrol in NHIP compared to households that did not have such experience. Similarly, households in which at least one of the members was chronically ill were 1.8 times more likely to enrol compared to households with no chronic illness.
Conclusion: Belonging to the privileged ethnic group, having a higher socio-economic status, experiencing an acute illness and presence of chronically ill member in the family are the factors associated with enrolment of households in NHIP. This study revealed gaps in enrolment between rich-poor households and privileged-underprivileged ethnic groups. Extension of health insurance coverage to poor and marginalized households is therefore needed to increase equity and accelerate the pace towards achieving universal health coverage.
Recent Advances in Evidence Based Public Health PracticePrabesh Ghimire
This product is the result of compilation from various sources. I acknowledge all direct and indirect sources although they have not been mentioned explicitly in the document.
Observational analytical study: Cross-sectional, Case-control and Cohort stu...Prabesh Ghimire
This presentation provides overview of three observational analytical studies: cross-sectional study design, case-control study design and cohort study design
Development of test instruments
Includes information about:
Methods of collecting information
Interview techniques and tools
Observation: concept and observation checklist
This is the product of compilation from various sources. I would like to acknowledge all direct and indirect sources although they have not been mentioned explicitly within the document.
This product is the result of compilation from various sources. I would like to acknowledge all direct and indirect sources, although they have not been explicitly mentioned within the document.
This product is the result of compilation from various sources. I acknowledge all direct and indirect sources although they have not been mentioned explicitly in the document.
New Organogram of Nepalese Health System (Please check the updated slides on ...Prabesh Ghimire
This slide has been updated to accommodate the recent changes. Please check the following link for the updated presentation:
https://www.slideshare.net/PrabeshGhimire/organogram-organization-structure-of-nepalese-health-system-updated-nov-2021
Bilateral and Multilateral Organizations in NepalPrabesh Ghimire
Declaration: The materials incorporated in this document have come from variety of sources and compiler bears no responsibilities for any information contained herein. The compiler acknowledges all the sources although references have not been explicitly cited for all the contents in this document.
Declaration: The materials incorporated in this document have come from variety of sources and compiler bears no responsibilities for any information contained herein. The compiler acknowledges all the sources although references have not been explicitly cited for all the contents in this document.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
3. Nazi Human Experimentation
• Early to mid 1940s, during World War II and the Holocaust.
• Nazi human experimentation: series of medical experiments on
large numbers of prisoners, including children
• By Nazi Germany in its concentration camps
• Nazi physicians and their assistants forced prisoners into
participating in experiments.
• Typically, the experiments resulted in death, trauma,
disfigurement or permanent disability, and as such are
considered examples of medical torture.
Prabesh Ghimire, MPH 3
4. Nazi Human Experimentation
• Series of experimentation
• Experiments on twins
• Bone, muscle, and nerve transplantation experiments
• Head injury experiments
• Freezing experiments
• Malaria experiments
• Immunization experiments
• Epidemic jaundice
Prabesh Ghimire, MPH 4
5. Nazi Human Experimentation
• Series of experimentation
• Mustard gas experiments
• Sulfonamide experiments
• Sea water experiments
• Sterilization and fertility experiments
• Experiments with poison
• Incendiary bomb experiments
• High altitude experiments
• Blood coagulation experiments
Prabesh Ghimire, MPH 5
8. Tuskegee Syphilis Study (1932-1972)
• Tuskegee Study of Untreated Syphilis in the Negro Male
• conducted between 1932 and 1972 by the U.S. Public Health
Service
• The purpose of this study was to observe the natural history of
untreated syphilis
• The African-American men in the study were only told they were
receiving free health care from the United States government.
• Public Health Service worked in collaboration with Tuskegee
University, a historically black college in Alabama.
Prabesh Ghimire, MPH 8
9. Tuskegee Syphilis Study (1932-1972)
• Investigators enrolled in the study a total of 600 impoverished,
African-American sharecroppers from Alabama
• Of these men, 399 had latent syphilis and 201 did not have the
disease
• The men were given free medical care, meals, and free burial
insurance for participating in the study.
• The men were told that the study was only going to last six
months, but it actually lasted 40 years
Prabesh Ghimire, MPH 9
11. Tuskegee Syphilis Study (1932-1972)
• After funding for treatment was lost, the study was continued
without informing the men that they would never be treated.
• None of the men were told that they had the disease, and none
were treated with penicillin even after the antibiotic was proven
to successfully treat syphilis.
• By 1947, penicillin had become the standard treatment for
syphilis.
• Choices available to the doctors involved in the study might
have included treating all syphilitic subjects and closing the
study, or splitting off a control group for testing with penicillin.
Prabesh Ghimire, MPH 11
12. Tuskegee Syphilis Study (1932-1972)
• The Tuskegee scientists continued the study without treating
any participants;
• they withheld penicillin and information about it from the patients.
• scientists prevented participants from accessing syphilis treatment
programs available to other residents in the area
• The victims of the study, all African American, included
• numerous men who died of syphilis, 40 wives who contracted the
disease, and 19 children born with congenital syphilis.
• Led to 1979 Belmont Report
• On May 16, 1997, President Bill Clinton formally apologized on
behalf of the United States to victims of the experiment.
Prabesh Ghimire, MPH 12
13. Guatemala Study
• Conducted from 1946-1948
• US Sponsored medical study
• nearly 700 men and women—prisoners, soldiers, mental
patients—were intentionally infected with syphilis
• hundreds more people were exposed to other sexually transmitted
diseases as part of the study) without their knowledge or consent.
• The purpose of the study was to determine whether penicillin
could prevent, not just cure, syphilis infection.
• Some of those who became infected never received medical
treatment.
Prabesh Ghimire, MPH 13
14. Guatemala Study
• Study took place with the cooperation of Guatemalan
government officials
• The study results were never published
• The records of the Guatemala experiments were uncovered
after the lead researcher's' death
• Findings was shared with US government officials in 2010
• Secretary of State Hillary Clinton AND Secretary of HHS issued
an apology for the STD study
• President Obama called the Guatemalan president to apologize
for the experiments
Prabesh Ghimire, MPH 14
16. Ethics
• Greek word: "Ethos": Custom or character
• Norms of conduct that distinguish between acceptable and
unacceptable behaviour
• Deals with the dynamics of decision making concerning what is
right and wrong
• Ethics in health research deals with the conflicts of interest
across various levels
Prabesh Ghimire, MPH 16
17. Ethical Principles on Health Research
• Nuremberg Code, 1947
• Contains 10 principles
• Helsinki Declaration (18th General Assembly of WMA), 1964
• Contains 32 principles
• Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research 1979
• International Ethical Guidelines for Biomedical Research
involving Human Subjects (1982)
• Nepal: Ethical guidelines for Health Research (NHRC)
Prabesh Ghimire, MPH 17
18. Four Principles of Biomedical Ethics
Given by Beauchamp and Childress
• Respect of autonomy
• non-maleficence
• beneficence, and
• justice
Prabesh Ghimire, MPH 18
19. The Nuremberg Code,1947
• The voluntary consent of the human subject is absolutely
essential
• The experiment should be such as to yield fruitful results
• The experiment should be so designed and based on the
results of animal experimentation and a knowledge of the
natural history of the disease or other problem under study, that
the anticipated results will justify the performance of the
experiment.
• The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.
Prabesh Ghimire, MPH 19
20. The Nuremberg Code
• No experiment should be conducted, where there is an a priori
reason to believe that death or disabling injury will occur
• The degree of risk to be taken should never exceed that
determined by the humanitarian importance of the problem
to be solved by the experiment.
• Proper preparations should be made and adequate facilities
provided to protect the experimental subject against even
remote possibilities of injury, disability, or death.
Prabesh Ghimire, MPH 20
21. The Nuremberg Code
• The experiment should be conducted only by scientifically
qualified persons.
• During the course of the experiment, the human subject should be
at liberty to bring the experiment to an end, if he has reached the
physical or mental state, where continuation of the experiment
seemed to him to be impossible
• During the course of the experiment, the scientist in charge must
be prepared to terminate the experiment at any stage, if he has
probable cause to believe, in the exercise of the good faith, superior
skill and careful judgement required of him, that a continuation of the
experiment is likely to result in injury, disability, or death to the
experimental subject.
Prabesh Ghimire, MPH 21
22. General Ethical Principles in Health
Research
Principle of Essentiality
• Whether the research is considered to be absolutely essential
after a due consideration of the existing scientific knowledge in
the proposed area of research.
• Is research likely to benefit the humanity or environment?
Prabesh Ghimire, MPH 22
23. General Ethical Principles in Health
Research
• Volunteerism and informed consent
• Research participants should be fully apprised of the research and the
associated risks and benefits.
• The participants should be informed of the right to abstain from the
research or withdraw consent at any time.
• In case a person is incapable of giving consent, a legally acceptable
guardian should give the informed consent.
Prabesh Ghimire, MPH 23
24. General Ethical Principles in Health
Research
• Non-exploitation
• The participants should be fully apprised of all the possible dangers
that may arise during the research so that they can appreciate all the
physical and psychological risks.
• Each research should include an in-built mechanism for compensation
for the human participants either through insurance cover or by any
other appropriate means to cover foreseeable and unforeseeable risks,
and provide remedial action and comprehensive aftercare.
Prabesh Ghimire, MPH 24
25. General Ethical Principles in Health
Research
• Privacy and confidentiality
• The identity and records of the participants are as far as possible kept
confidential (except when required for legal reasons).
• This is to avoid any form of hardship, discrimination or stigmatization as
a consequence of having participated in the research.
Prabesh Ghimire, MPH 25
26. General Ethical Principles in Health
Research
• Principles of the maximization of the public interest and of
distributive justice
• The research or experiment and its subsequent application should be
conducted and used to benefit all human kind (and not just those who
are socially better off), in particular, the research participants
themselves and or the community from which they are drawn.
• Professional competence
• Research should be conducted by competent and qualified persons
who act with total integrity and impartiality and who have been made
aware of the ethical considerations to be borne in mind in respect of
such research or experiment.
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27. General Ethical Principles in Health
Research
• Principles of accountability and transparency
• The research or experiment should be conducted in a fair, honest, impartial,
and transparent manner
• Full and complete records of the research should be retained for such
reasonable period
• Stakeholders (researchers, ERB members, regulators and sponsors) involved
in the particular research should disclose any existing Conflict of Interest
(CoI)
• Principles of public domain
• The research findings should be brought into the public domain so that its
results are generally made known through scientific and other publications.
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28. For Further Reading
• Avasthi, A., Ghosh, A., Sarkar, S., & Grover, S. (2013). Ethics in medical research:
General principles with special reference to psychiatry research. Indian journal of
psychiatry, 55(1), 86–91. doi:10.4103/0019-5545.105525
• Cash, R., Wikler, D., Saxena, A., Capron, A. M., & World Health Organization.
(2009). Casebook on ethical issues in international health research. World Health
Organization.
• NHRC (2019). National Ethical Guidelines for Health Research in Nepal. Kathmandu
Nepal Health Research Council (NHRC) Ramshah Path, Kathmandu, Nepal.
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30. 1.Informed consent
• Informed consent: mandatory for study involving human
participants
• Should be voluntary, without pressure or coercion or undue
inducements
• For participants aged 18 years and above: Written consent
• For children aged >12 to <18 years: Written assent
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31. 1. Informed consent
• For children aged 7 to <12 years: written assent not required
• Obtain verbal assent in presence of the parents or legal representative
• Children <7 years: Written proxy consent from parent or legally
accepted representative
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32. 1. Informed consent
• Sufficient information to be provided:
• research procedures, their purposes, risks, discomforts, anticipated
benefits
• Statement offering opportunity to ask questions
• Right to withdraw at any time
• Information to be provided in a language that participant can
understand
• If participant not capable to comprehend, proxy consent of a
legally accepted representative should be taken
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33. Consent in special situations
• Consent from gatekeepers
• Community consent
• Consent from vulnerable groups
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34. 2. Research among vulnerable
Populations
• Investigating team must ensure that extra efforts are in place to
protect the rights, dignity, safety and well being of vulnerable
populations
• If vulnerable people lack the ability to consent, a legally
acceptable representative must be involved in decision making
procedure.
• Privacy and confidentiality of vulnerable people.
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35. Who are vulnerable population
• Children (<18 years)
• Elderly people (>60 years)
• Pregnant or lactating women
• Differently abled person
• Refugees, immigrants, migrant workers
• Slum dwellers
• Sex workers
• Under trial population
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36. Who are vulnerable population
• Victims of traumatic events (abuse, natural disasters, war)
• Individual with mental illness or cognitive impairment
• Individual with a life-threatening illness or condition
• e.g. HIV, cancer) or terminally ill persons
• Disadvantaged, marginalized, tribal and indigenous communities
• including ethnic and sexual minorities (e.g. orphans, persons below poverty
line, untouchables, LGBTI)
• Individuals who are highly dependent to follow the command under a
hierarchical system
• prisoners, para-public forces such as armies, polies, students, employees
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37. Additional safeguards for vulnerable
population
• Inclusion in the study must be justified
• No coercion, force, undue influence, threat or incentives for
participation during the investigating period
• Information about benefits, risks, and alternatives be provided in
own language
• Investigators to be careful on the potential conflict of interest
between vulnerable participant and legally acceptable
representative.
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38. Research involving children
• Health research which can be done in adults should not be
done in children.
• Should be carried out only after taking informed consent from
their parents or legally accepted representative.
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39. Research involving children
Research can be done in children only if
• Disease/condition is only seen in children
• Information cannot be generated by other alternative means
• Safety of drugs need to be checked among adult before
administration to children
• In case of children without immediate guardians such as street
children: approval from administrative authorities
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40. Research among reproductive age,
pregnant and lactating women
• Not to carry research unless study is related to pregnancy and
lactation
• In some groups of women, informed consent can be challenging
because of socio-cultural reasons.
• Consider women's autonomy and local cultural practices and
requirements
• Reproductive aged women should be informed of the probable
risk to the fetus if they become pregnant during the period of
their recruitment in the clinical trials.
• In case, if women become pregnant, they should not
automatically be removed from the clinical trial study
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41. 3. Privacy and Confidentiality
• Protect the confidentiality of research based information
provided by participants
• Not publish any information or photographs disclosing
participant's identity without consent
• Sensitive information- HIV or leprosy status, mental or social
status, sexual orientation- to be protected to avoid
stigmatization
• Considerations to be taken for protection of electronic data
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42. 4. Compensation and payment
• Researchers should have made provisions to compensate
participants for harms suffered during research process
• Provisions to be made for compensation of participant's efforts
and time for research process
• Reimbursement for expenses incurred for research participation
• Travel expenses
• Loss of earning (wage compensation)
• Loss of food supplies
• Participants should not be required to pay for any research
related expenses (except routine clinical care)
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43. 4. Compensation and payment
• Participants suffering from direct psychological, physical, social,
legal or economic harm from research participation are entitled
to financial or other assistance
• Dependents are entitled to financial compensation in the event
of death
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44. 5. Qualification and competence for
research
• Principal investigator should have basic knowledge of research
methodology and research ethics.
• should have a professional competency for research execution
• A researcher should not have any pre-conceived notion
• should maintain objectivity while collecting the data.
• A researcher must have at least basic idea of data analysis
• also must be able to interpret the outputs of the analyzed data sets,
and write the research report.
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45. 6.Data collection, storage, security and
transfer
• Primary and data collection sources should be well defined
• Research should explain how data will be stored (paper or
electronic)
• Need to mention- how many years such data will be kept of use
in future
• Details of measures to be taken for securing research data to
be mentioned
• Physical security of equipment
• Digital security mechanisms
• File cabinet security process like lock and key
• Data storage and back up plan
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46. 6. Data collection, storage, security and
transfer
• For sensitive data such as
• Medical records of PLHIV, TB/leprosy/cancer etc
• Police records of people involved in accidents, alcoholism, prostitution,
criminal proceedings, drug abuse
Regulatory permission from responsible authority of relevant section is
needed
• If data is being transferred to abroad, the reason should be
clearly mentioned in the proposal
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47. 7. Biological specimen collection,
storage, security and bio-banking
• Researcher should quantify the number of biological samples
and its volume to be collected from the targeted research
participants
• Explanations required on:
• How such specimens will be stored?
• At which temperature (short and long term)?
• Researchers must apply appropriate security system like lock
and key, digital door with password, surveillance camera
• Appropriate facilities, equipment, policies and procedures for
storage should be ensured
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48. 8. Transfer of biological specimen
• Justification to be provided for the study involving transfer of
biological samples to other countries
• If researcher (Nepali student) has an opportunity to test the bio-
samples at free of cost in abroad, he/she may ask permission to
ERB for transferring such bio-samples.
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50. Institutional Review Board (IRB)
• The Institutional Review Board (IRB): an administrative body of
an institution (particularly university/ academia/ international
organizations)
• Also called Independent ethics committee (IEC), Research
Ethics Board (REB), Institutional Review Committee (IRC)
• Established to protect the rights and welfare of human research
participants recruited to participate in research activities
conducted under the auspices of the institution with which it is
affiliated.
• In Nepal, currently there are 51 IRCs approved by NHRC
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51. Structure of IRB/IRC
• Structure: Usually have 5-6 members (but might vary)
• Members from varying backgrounds in order to provide
complete and adequate review of human research and its
institutional, legal, scientific and social implications.
• In Nepal every IRC team is multidisciplinary, having at least one
female member and one external member not affiliated with the
institution.
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52. Roles of IRB/IRC
• Responsibility for reviewing, prior to its initiation, all research
(whether funded or not) involving human participants.
• Ethical clearance to research proposals:
• The IRB has the authority to approve, disapprove, and require
modifications in research proposals from researchers within the
institution
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53. Roles of IRB/IRC
IRCs in Nepal are not authorized to provide approval to the
following research proposals:
• Research proposed intended for studies at the national or
international level
• Externally sponsored/funded research (the term “externally”
indicates not only outside of the country but also outside of the
particular health care facility or institution)
• Clinical trials involving human and/or animal participants
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55. Ethical Review Board (ERB)
• ERB: Independent board to review scientific quality and ethical
standard of the research proposals involving human
participants.
• Formed by Nepal Health Research Council
• Includes: 7-15 members from different fields
• ERB members are non-affiliated to NHRC executive board
(except member secretary of ERB)
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56. Roles and Functions of ERB
• Review and ensure the rights, dignity, safety and well-being of
human research participants and comply with national and
international guidelines
• provide constructive feedback with a view to approve, or disapprove
the submitted research proposal
• Monitor the research activities for ensuring that the research is
conducted according to the proposal approved by the ERB
• investigate if there is any breach/violation/deviation in approved
proposal.
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57. Roles and Functions of ERB
• Accountable of any sort of research misconduct of the approved
proposals.
• Provide assistance and facilitate the researchers for conducting
research adhering to the ethical guidelines.
• Provide approval for accreditation of IRCs, guide them
periodically and oversee their functions and duties.
• Conduct meeting/workshop/training programs for members of
IRCs and proposal reviewers on the ethical review process.
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58. Roles and Functions of ERB
• Oversee the health researches involving human participants
and analyze complaint(s) (if any) related to unethical conduct of
research in the country and take appropriate decisions for
actions, and
• Facilitate and provide protection to the researchers if necessary.
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